510(k) Report

Devices descending from K875179

27 later devices reach Modified Laserflo Blood Perfusion Monitor, BPM403A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K951832Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433Vasamedics, LLC199626—
+2K013376Qflow 500 Perfusion Monitoring SystemHemedex Incorporated20020—
+2K962700Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring…Vasamedics, LLC19971—
+2K961368Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC199624—
+3K013930NeurosensorNovus Monitoring, Ltd.200222—
+4K050702Neurosystems 1TM MonitorNeurosystems, LLC200517—
+4K050720Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models…Integra Neurosciences200511
+4K042728Camino Slim-Line Intracranial Monitoring SystemNovus Monitoring, Ltd.20041—
+5K172209Aura Icp Monitoring SystemBranchpoint Technologies, Inc.20180—
+5K101133Sensometrics SoftwareDpcom AS20100—
+5K071505Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring…Integra LifeSciences Corporation200701
+5K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation200615—
+6K080217Component Neuromonitoring SystemMoberg Research, Inc.2008141
+7K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20201—
+7K191868iCEWav Neuromonitoring PlatformIce Neurosystems, Inc.20200—
+7K192572CNS EnvisionMoberg Research, Inc.20190—
+7K173366NicoletOneNatus Neurology Incorporated20183—
+7K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc.20107—
+8K251881HippoMind (v1.0)Hippoclinic20250—
+8K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+8K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+8K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+9K213299Wireless EEG SystemPascall Systems, Inc.20222—
+9K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+9K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+10K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+10K240593VEEGix EEG SystemNeuroServo, Inc.20240—